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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameINTERSTIM THERAPY SYSTEMS
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP080025
Supplement NumberS016
Date Received07/25/2011
Decision Date04/10/2012
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating the labeling to allow particular types of mri scans to be performed while the devices are implanted and for associated changes in the product specification of model 3023 interstim neurostimulator.
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